25 
late drinking water, milk and animal products, shellfish and pet 
turtles that might pose a danger to public health. Even noninfectious 
materials have been regulated. These applications, according to Press, 
show a clear “preference for prevention of the occurrence of any risk, 
rather than control of the spread of infection.” In the absence of con- 
clusive evidence to the contrary, the possibility that recombinant DXA 
research on nonhuman animal or plant materials could result in human 
infection would justify comprehensive regulation of the research 
under this authority. For these reasons, the Office of Science and 
Technology Policy reserves the option of recommending that regula- 
tions be issued under section 361 if legislation is long delayed. 
Views of the subcommittee 
The subcommittee believes that the Federal Government should 
rely on full legal authority in regulating all recombinant DNA re- 
search regardless of its locale or sources of financial support. A pro- 
gram of voluntary compliance by and monitoring of industrial 
research activities is insufficient. Whatever form such a program might 
take, it would leave unclear the status of privately supported, research 
in universities. Moreover, because it would require the consent of all 
participants, there is no assurance that it would achieve universal 
coverage in the private sector. It would not afford those subject to it 
an adequate voice in the drafting or subsequent revision of the guide- 
lines. The lack of effective sanctions for violations would undermine 
public confidence that the guidelines were being observed. Finally, 
duplication in the Department of Commerce of expertise which 
resides in the Department of Health, Education, and Welfare and 
elsewhere would be wasteful and unnecessary. 
The subcommittee agrees that the Occupational Safety and Health 
Act, the Toxic Substances Control Act, the Food. Drug and Cosmetic 
Act and other specialized public health and environmental protection 
statutes do not provide adequate authority to regulate all research 
with recombinant DNA, although, as Secretary Califano observed in 
his letter to the subcommittee, the Food and Drug Administration 
“* * * could, under existing authority, require any firm seeking ap- 
proval of a product which may be the end product of recombinant 
DNA research to certify to the Agency that it has complied with the 
NIH Guidelines on recombinant DNA,” and could inspect firms mak- 
ing such certification. Use of this authority, even though it would 
apply, only after the research had been conducted, would be an impor- 
tant incentive for companies subject to the food and drug laws to com- 
ply with the NIH standards. Furthermore, as the Interagency Com- 
mittee observed OSHA, FDA, and EPA will have important roles 
to play when recombinant DNA techniques reach the stage of com- 
mercial application. (See Applicability of Existing Statutes, p. 41.) 
The subcommittee is not persuaded that the legal obstacles to use 
of section 361 of the Public Health Service Act are insuperable. While 
it is the case that no person is known to have been injured by ex- 
posure to recombinant DNA material, the possibility of unintention- 
ally transferring a pathogenic characteristic capable of causing 
disease in laboratory workers or others in the surrounding environ- 
ment is the principal concern that led to the Asilomar conference rec- 
ommendations, the NIH guidelines, and the similar precautionaiy 
[Appendix B — 284] 
